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BS EN 16844:2017+A2:2019

$198.66

Aesthetic medicine services. Non-surgical medical treatments

Published By Publication Date Number of Pages
BSI 2019 56
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This European Standard addresses the requirements for certain aesthetic non-surgical medical treatments:

  • treatments with resorbable injectables, botulinum toxin and micro needling;

  • treatments with non-ablative fractional resurfacing and superficial peels, lasers and comparable energy based devices;

  • treatments with fractional ablative lasers and comparable energy based devices and medium depth peels; and

  • other treatments such as deep chemical peels, full ablative lasers and thread lifts.

This European Standard provides recommendations for aesthetic non-surgical medical treatments, including the ethical framework and general principles according to which aesthetic medicine services are provided by all practitioners and stakeholders of the aesthetic medical field. These recommendations apply before, during and after the treatment.

Any aesthetic medical treatment that goes deeper than the stratum corneum or which has, or claims to have, a biological effect beyond the stratum corneum (with or without instrument or devices) is included in the scope of this European Standard.

Aesthetic surgical procedures covered by EN 16372 and dentistry1) procedures are excluded from the scope of this European Standard.

Aesthetic non-medical treatments (tattooing and any treatment not affecting tissue deeper than the stratum corneum) which can be legally performed by non-physicians (e.g. tattooist, beauty therapists) are excluded from the scope of this European Standard.

PDF Catalog

PDF Pages PDF Title
2 National foreword
8 1 Scope
2 Terms and definitions
10 3 Competencies
3.1 General
11 3.2 Training
3.3 Continuous professional development (CPD) and continuous medical education (CME)
4 Management and communication with patients
4.1 Office staff/Booking arrangements
12 4.2 Patient consultation and assessment
13 4.3 Consent
14 4.4 Documentation
15 4.5 Post-treatment follow up and patient satisfaction
4.6 Advertising
16 4.7 Medical tourism and travelling long distance for treatment
17 4.8 Medical indemnity and insurance
4.9 Fees
4.10 Arrangements for out of hours and emergency cover
18 4.11 Complaints
4.12 Confidentiality
4.13 Safe timing of treatments
4.14 Registration
5 Facilities
5.1 Evaluation of compliance and risk management
5.2 Personnel
19 5.3 Documentation of medical records
5.4 Facility
5.5 Administrative and waiting area
5.6 General requirements and recommendations for treatment rooms and procedure rooms
20 5.7 Patient safety and security
21 5.8 Hygiene standards for treatment rooms and procedure rooms
22 5.9 Medicines Management
23 5.10 Treatment room (TR)
5.11 Procedure room (PR)
25 6 Treatments
6.1 General
6.2 Aesthetic medical treatment categories
6.3 Identifying factors
6.3.1 General
26 6.3.2 Practitioner
6.3.3 Facility
6.3.4 Anaesthesia level
6.3.5 Risk level of treatment
27 6.3.6 Patient physical status and age
28 6.3.7 Mental status and patient expectations
6.4 Treatment identification
6.5 Cooling off period
6.6 Aesthetic medical treatments
31 Annex A (normative)Code of Ethics for marketing and advertising
33 Annex B (informative)A–deviations
BS EN 16844:2017+A2:2019
$198.66